Japan's health regulator approves Novo Nordisk's Ryzodeg
Japan's health regulator has approved Novo Nordisk's new medication combination, Ryzodeg, for the treatment of diabetes, Reuters reports. The Danish company has also filed for approval of the drug in the European Union, Canada and Switzerland, among other countries. Reuters suggests that competition in the diabetic pharmaceuticals market for long-acting insulin could heat up as a result.
"We are excited about the approval of Ryzodeg," Mads Krogsgaard Thomsen, executive vice president and chief science officer of Novo Nordisk, said in an announcement published by Novo Nordisk. "The unique properties of Ryzodeg provide the potential to improve treatment for people with diabetes in Japan."
According to Reuters, Ryzodeg is a combination of Novo Nordisk's new ultra-long-acting insulin, Tresiba, and its rapid-acting insulin, NovoRapid. Japan became the first country to approve Tresiba in September 2012, but the drug faced a setback in November 2012 when U.S. regulators said it posed a higher heart safety risk than other diabetes treatment. The United States is where Novo Nordisk hopes to generate the majority of its sales. Reuters notes that Ryzodeg has potential as a new competitor in the long-acting, or basal, insulin market, which is currently dominated by Sanofi's Lantus. Eli Lilly also reportedly has a promising new basal insulin in development.
"We see a lot of exciting share price drivers ahead and expect the stock to take off in 2013 and set records," Mikkel Pedersen, an analyst at Nordea Bank AB, told Bloomberg.
According to Bloomberg, Novo Nordisk hopes to start selling Ryzodeg in Japan later in 2013, about six to nine months after introducing Tresiba to the market. Novo Nordisk plans to offer the drug in both FlexTouch -- the company's latest prefilled insulin pen with an auto-injector mechanism -- and Penfill insulin pens.
"Japan approves Novo's new combination insulin Ryzodeg," reuters.com, December 25, 2012
"Novo Nordisk Gains as Japan Approves Ryzodeg: Copenhagen Mover," bloomberg.com, December 27, 2012, Gelu Sulugiuc
"Ryzodeg (insulin degludec/insulin aspart) approved in Japan," novonordisk.com, December 25, 2012